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Gap Assessment - IVD - GiDoS

IVDD & IVDR Comparison: Essential Safety and Performance Requirements

A comparative analysis of the Essential Requirements and differences between the texts of the Directive and the Regulation on in vitro diagnostic medical devices. The document simplifies the gap analysis by listing requirement per requirement, with additional column to add your own comments (Applicable /Not Applicable).

PREVIEW: Comparison -Essential Safety and Performance Requirements IVDR

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